Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
NCT ID: NCT01134562
Last Updated: 2018-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2010-09-07
2011-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
Placebo
Single IV injection.
Etelcalcetide
Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
Etelcalcetide
Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
Interventions
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Placebo
Single IV injection.
Etelcalcetide
Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and \< 1200 pg/ml for Cohorts 1-3).
* Serum corrected calcium ≥ 9.0 mg/dL
* Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea \* dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)
≥ 65%.
* Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests
Exclusion Criteria
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
* History of or treatment for seizure disorder
* Recent (3 months) parathyroidectomy
18 Years
ALL
No
Sponsors
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KAI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Bell, MD
Role: STUDY_DIRECTOR
KAI Pharmaceuticals
Locations
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Cypress, California, United States
Shreveport, Louisiana, United States
Houston, Texas, United States
Brisbane, Queensland, Australia
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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20130139
Identifier Type: OTHER
Identifier Source: secondary_id
KAI-4169-002
Identifier Type: -
Identifier Source: org_study_id
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